Status:
RECRUITING
Effect of Fetal Aortic Valvuloplasty on Outcomes
Lead Sponsor:
Queen Silvia Children's Hospital, Gothenburg, Sweden
Collaborating Sponsors:
Swedish Heart Lung Foundation
Sahlgrenska University Hospital
Conditions:
Congenital Heart Disease
Aortic Valve Stenosis
Eligibility:
All Genders
23-31 years
Brief Summary
In one of the most severe congenital heart defects, hypoplastic left heart syndrome (HLHS), the left ventricle is underdeveloped and the prognosis is worse than in most other heart defects. The underd...
Detailed Description
Routinely collected pre- and postnatal clinical data will be entered into a digital database and echocardiographic examinations will be uploaded to a server. A core lab will measure and analyze all ec...
Eligibility Criteria
Inclusion
- A. All of the following echocardiographic criteria need to be satisfied between 23+0 and 31+6 weeks (z-scores according to Schneider et al):
- Aortic valve stenosis with antegrade flow through the valve
- Predominantly left-to-right shunt at the atrial level
- Predominantly retrograde flow in the aortic arch between the first two brachiocephalic vessels
- Qualitatively depressed left ventricular function
- Left ventricular end-diastolic diameter Z-score \> ±0
- Left ventricular inlet length in diastole :
- Gestational age ≤ 24+6: Z-score \> ±0
- Gestational age 25+0 to 27+6: Z-score \> -0.75
- Gestational age ≥ 28+0: Z-score \> -1.50
- Mitral valve diameter in diastole Z-score \> -2.0
- B. All of the following postnatal treatment options need to be available: 1. Surgical or catheter based aortic valvotomy 2. Ross-Konno surgery 3. Norwood or hybrid stage-one surgery
Exclusion
- Any associated cardiac defect except persistent left superior vena cava and coarctation of the aorta
- Any significant (i.e. that might influence outcome) extracardiac anomaly and/or known chromosomal aberration. Also, if such a condition is present at inclusion but diagnosed only after birth the case will be retrospectively excluded.
Key Trial Info
Start Date :
January 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05386173
Start Date
January 1 2021
End Date
December 31 2029
Last Update
March 21 2025
Active Locations (13)
Enter a location and click search to find clinical trials sorted by distance.
1
Fetal Cardiovascular Program, University of California San Francisco
San Francisco, California, United States, 94158
2
Congenital Heart Collaborative, Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
3
Kinderherzzentrum Linz
Linz, Austria
4
The Hospital for Sick Children Toronto
Toronto, Canada